Reinspection lands Alexion with 483 for Soliris plant

Reinspection lands Alexion with 483 for Soliris plant

26-Aug-2014 - A US FDA reinspection of Alexion’s Rhode Island facility hit with a warning letter last year has resulted in a Form 483 with three observations.

Patheon granted Schedule I manufacture of GHB at Ohio plant

DEA approves manufacture of GHB at Patheon Cincinnati plant

26-Aug-2014 - Patheon has received approval from the DEA to bulk manufacture the schedule I product Gamma Hydroxybutyric Acid (GHB) from its facility in Cincinnati, Ohio.

Samsung HQ in Seoul, South Korea

EMD Millipore to supply Samsung's Yervoy plant in 10-year deal

26-Aug-2014 - EMD Millipore has been contracted to supply raw materials to the Samsung Biologics plant where ingredients for BM-S’ anticancer monoclonal antibody Yervoy (ipilimumab) are made.

USP joins campaign against illegal online pharmacies

USP joins campaign against illegal online pharmacies

26-Aug-2014 - Drug quality and standards organisation USP has joined a campaign to raise awareness about the risks posed by illegal online pharmacies.

Do try to supply Argentina Indian drugmakers told by Gov

Argentina to allow Indian drug imports after inspecting five plants

25-Aug-2014 - Argentina decided to allow Indian drug imports after inspecting just five of the country's 793 manufacturing facilities according to documents released this week.

People on the Move at GSK, Allergan, Novartis

People on the Move at GSK, Allergan, Novartis

25-Aug-2014 - Our weekly round-up of the bright young things and big cheeses in pharmaceuticals.

A chest radiograph of a patient with Idiopathic Pulmonary Fibrosis (IPF). Roche has paid $8.3bn for InterMune and its IPF drug, set to launch in the US later this year

Catalent contract secure as Roche buys InterMune for $8.3bn

25-Aug-2014 - Roche has bought InterMune for $8.3bn (€6.3bn) and says it will continue contracts with Catalent and two API suppliers for the manufacture of its lead product Esbriet (pirfenidone).

EFPIA, EGA take issue with EMA’s guidance on stability data

EFPIA, EGA take issue with EMA’s guidance on stability data for APIs

25-Aug-2014 - EFPIA (European Federation of Pharmaceutical Industries and Associations) and EGA (European Generics Association) have released comments suggesting specific changes to the EMA’s draft guidance on stability data for manufacturing changes.

Xcellerex site in Marlborough, Massachusetts, US

GE Healthcare: plans to move New Jersey ops to new Massachusetts HQ

22-Aug-2014 - GE Healthcare has said it plans to relocate operations in New Jersey to its new Massachusetts life sciences headquarters.

GSK welcomes US OK for Arnuity in light of declining Advair sales

GSK welcomes US OK for Arnuity in light of declining Advair sales

21-Aug-2014 - US FDA approval of the inhaled corticosteroid (ICS) asthma drug Arnuity will help offset declining sales of the off-patent bestseller Advair, says GlaxoSmithKline.

Claris gets MHRA OK for injectables plant

Claris gets MHRA OK for injectables plant

21-Aug-2014 - Indian manufacturer Claris Lifesciences has had its injectable drug manufacturing facility in Ahmedabad approved by the UK MHRA.

Ben Venue site has no place in injectables network, says Hikma

Ben Venue site has no place in injectables network, says new owner Hikma

21-Aug-2014 - Ben Venue Laboratories will remain inactive says new owner Hikma as it looks to optimise its injectables manufacturing network.

Macfarlan Smith fined $12,000 after accident at API plant

Macfarlan Smith fined $12,000 after accident at API plant

21-Aug-2014 - Opiate API manufacturer Macfarlan Smith has been fined £12,000 for failing to ensure the safety of an employee injured at its plant in Scotland in 2011.

MHRA "Previously [drug] export outside the EEA was not covered by legislation"

UK drug exporters shipping outside the EEA must seek MHRA approval

20-Aug-2014 - EU law changes mean all UK firms handling pharmaceuticals for export outside the EEA must now be inspected and pay license fees according to the MHRA.

A five-year marketing period for new drugs excludes generics

Eisai sues FDA for ‘losing one year’ of marketing to generics rivals

20-Aug-2014 - Eisai has accused the US FDA of unlawfully shortening market exclusivity periods for Belviq and Fycompa by starting the countdown one year before either was scheduled by the DEA.

The effective date of affixing barcodes on mono-cartons as secondary level packaging has been deferred to 1st April, 2015.

India changes course, calls for bar codes for mono cartons in April

20-Aug-2014 - Nearly a month after India pushed back its deadline indefinitely for exporters to put bar codes on their primary packages, the Directorate General of Foreign Trade (DGFT) has set a new deadline of April 2015.

Frogs, fungus and falsified data - Indian firm falls foul of US FDA

Frogs, fungus and falsified data - Indian firm falls foul of US FDA

20-Aug-2014 - Indian drugmaker Amanta has received a warning letter after the US FDA found evidence of data falsification and unsanitary conditions – including dead and decaying frogs next to a product exit dock – during an inspection last year.

Novartis will have the option to fully acquire Gamida Cell

Novartis invests $35m in stem cell tech company with option to acquire

20-Aug-2014 - Novartis has invested $35m (€26.3m) for a 15% stake in Israel-based Gamida Cell, which offers stem cell expansion technologies and therapeutics.

US FDA 'stamp of approval' testament to WuXi's growth in APIs

US FDA 'stamp of approval' testament to WuXi's growth in APIs

19-Aug-2014 - WuXiPharmaTech has received US FDA approval to manufacture an API for a commercial drug from a plant in Shanghai.

Approved needle-free injection system

US FDA approves first needle-free flu vaccine delivery system

19-Aug-2014 - For the first time ever, the US FDA has approved a needle-free injection system to deliver the seasonal flu vaccine.